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Surgical FatigueNCT06978309

EMG Response in Forearm and Neck Muscles When Comparing Surgical Techniques.

An observational study of Surgical Fatigue, run by Lancaster University at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Surgeons are performing an increasing number of minimal access procedures because these offer certain advantages including improved recovery times. However, this also results in surgeons operating for longer periods which inevitably increases the already known prevalence of work-related Musculoskeletal (MSK) injuries… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Surgical Fatigue
How many people
9 participants
Where
1 siteUnited Kingdom
Study dates
6 May 2025to 8 Sep 2025
How long will I take part?
2 Weeks
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Healthy, adult laparoscopic and robot- assisted laparoscopic surgeons.

Who may be able to join

  • Either a laparoscopic or robot-assisted laparoscopic surgeon.
  • Good musculoskeletal health.
  • Adult.

Who cannot join

  • Procedures with major complications (above 50% more time than the average for that surgery).
  • Significant co- morbidities that could affect the results of the study. Significant symptoms of musculoskeletal disorder.
  • Anything the investigator feels will affect the study's measurements of safety.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Blackburn Royal Teaching Hospital

    Blackburn, Lancashire

Other trials in United Kingdom

About this study

Official title: Exploring the Difference in EMG Response of Forearm and Sternocleidomastoid Muscles When Comparing Laparoscopic Surgery (LS) and Robot Assisted Laparoscopic Surgery (RALS).

Surgeons are performing an increasing number of minimal access procedures because these offer certain advantages including improved recovery times. However, this also results in surgeons operating for longer periods which inevitably increases the already known prevalence of work-related Musculoskeletal (MSK) injuries amongst surgeons. Work-related MSK disorders account for 26 - 47.5% of illnesses and injuries due to overexertion and repetitive use, in professionals with ergonomically challenging jobs. Robotic-assisted laparoscopic surgery (RALS) is a modern technology that could help mitigate these MSK problems and thereby improve patient care. In comparison to standard laparoscopic surgery (LS), RALS offers steadier wrist movements with a reduced fulcrum effect, thus benefiting the patient.

No study has compared the demands of RALS vs. LS on musculoskeletal fatigue (and subsequent injury risk). The investigators need to determine whether a career using RALS is associated with better musculoskeletal health of surgeons than standard LS when performing complex minimally invasive procedures.

Read more

The study will recruit Surgeons who perform prostate and bowel surgical procedures who have experience using RALS and/or LS. Surgeons will complete a series of validated questionnaires before and after each surgery to subjectively determine musculoskeletal strain/pain and will have body composition quantified.

They will be fitted with EMG (to measure muscle fatigue) whilst performing real-life surgery. Analysis of data gathered will be used to show what the short- and long- term musculoskeletal demands are and in turn determine if these are associated with changes in motor control.

The researcher's postulated hypothesis is that RALS should have less musculoskeletal effects both short and long term on surgeons, therefore, highlighting the fact that the implementation of RALS should be less controversial, because in the long run, the most expensive objects in the operating room are the personnel.

Being tested
No Interventions
Keywords
fatigue, Laparoscopic, Surgeon wellbeing, Robotic surgery, EMG
Medical subject headings
Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No InterventionsOther

    Observational study.

Study groups in NCT06978309
Study groupRoleWhat they receive
Robot-Assisted Laparoscopic SurgerySurgeons performing robot assisted laparoscopic surgery.
Receives: Other: No Interventions
Laparoscopic SurgerySurgeons performing manual laparoscopic surgery.
Receives: Other: No Interventions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acute muscle activation- percentage of forearm maximal voluntary contraction (%) assessed using EMG frequency.

    This outcome measures the immediate impact of RALS and LS on the surgeon's forearm muscles during a single surgical procedure. It will be quantified by assessing the change in electromyography (EMG) frequency and amplitude recorded during clinically important surgical tasks within the surgeons' first surgery of the day. The contributing measures to this primary measure are the maximal voluntary contraction that will be assessed just before the surgery begins, and the average frequency of muscle activation (mV) over the 2 minute data collection period. Muscle activation for RALS and LS will be compared using this measure.

    Measured: Intraoperative

Secondary outcomes (8)
  1. Surgeon musculoskeletal health over the last 12 months (Standardized Nordic Questionnaire)

    This questionnaire assesses musculoskeletal symptoms experienced by the surgeons within the last 12 months. It helps to understand the prevalence and location of pain and discomfort before they participate in the study. This questionnaire primarily yields categorical data. For each of the nine body regions (neck, shoulders, upper back, elbows, low back, wrists/hands, hips/thighs, knees, ankles/feet), it asks about trouble (ache, pain, discomfort) in the past 12 months and in the past 7 days. It also asks if the trouble prevented normal work (at home or away from home).

    Measured: Preoperative

  2. Surgeon physical activity participation status (International Physical Activity Questionnaire

    The frequency, duration, and intensity of different types of physical activities (vigorous, moderate, walking, and sitting) undertaken by the surgeons. It aims to quantify their overall physical activity level. Can be reported as continuous scores (Metabolic Equivalent of Task - minutes per week, or MET-min/week) calculated by multiplying duration, frequency, and standard MET intensity values for each activity type. It can also be categorized into low, moderate, and high physical activity levels based on specific criteria related to frequency, duration, and total MET-min/week.

    Measured: Preoperative

  3. Surgeon well-being and quality of life (SF36 Health and Wellbeing Questionnaire)

    This assesses the surgeon's health-related quality of life across eight dimensions: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, General Health Perceptions, Vitality (energy/fatigue), Social Functioning, Role Limitations due to Emotional Problems,1 and Mental Health (emotional well-being). This yields eight scaled scores ranging from 0 to 100, with higher scores indicating better health status in each dimension. Scoring involves recoding items, summing within scales, and then transforming to the standardized range using specific algorithms. Summary scores (PCS and MCS) can also be calculated.

    Measured: Preoperative

  4. Maximal Voluntary Contraction measured using EMG (mV)

    This will take place with the surgeon producing the a maximal contraction for both their forearm muscles and neck muscles in to create a baseline of comparison to calculate the percentage of maximal contraction that the surgeons experience during surgery.

    Measured: Intraoperative

  5. Acute muscle activation- percentage of sternocleidomastoid maximal voluntary contraction (%) assesed using EMG frequency.

    This outcome measures the immediate impact of RALS and LS on the surgeon's sternocleidomastoid muscles during a single surgical procedure. It will be quantified by assessing the change in electromyography (EMG) frequency and amplitude recorded during clinically important surgical tasks within the surgeons' first surgery of the day. The contributing measures to this primary measure are the maximal voluntary contraction that will be assessed just before the surgery begins, and the average frequency of muscle activation (mV) over the 2 minute data collection period. Muscle activation for RALS and LS will be compared using this measure.

    Measured: Intraoperative

  6. Average sternocleidomastoid and forearm muscle EMG amplitude (mV)

    This will be measured using EMG at clinically significant points in the surgery. This will allow for the researchers to assess the muscular demand and the amplitude and frequency of the EMG signal are the direct measures used to quantify this primary variable. Lower amplitude means a greater muscular demand.

    Measured: Intraoperative

  7. Average sternocleidomastoid and forearm muscle EMG frequency (Hz).

    This will be measured using EMG at clinically significant points in the surgery. This will allow for the researchers to assess the muscular demand and the amplitude and frequency of the EMG signal are the direct measures used to quantify this primary variable. Higher frequency means greater muscular demand.

    Measured: Intraoperative

  8. Surgeon musculoskeletal health over the last 12 months (Standardized Nordic Questionnaire)

    This questionnaire assesses musculoskeletal symptoms experienced by the surgeons within the last 12 months. It helps to understand the prevalence and location of pain and discomfort before they participate in the study. This questionnaire primarily yields categorical data. For each of the nine body regions (neck, shoulders, upper back, elbows, low back, wrists/hands, hips/thighs, knees, ankles/feet), it asks about trouble (ache, pain, discomfort) in the past 12 months and in the past 7 days. It also asks if the trouble prevented normal work (at home or away from home).

    Measured: Any time between enrolment in the study and the date of the surgical procedure that the data collection will take place.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2025
  2. Study start6 May 2025
  3. Primary completion8 Sep 2025
  4. Study completion8 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
9 participants (actual)
Target duration
2 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT06978309
Sponsor's protocol ID
FHM-2025-4948-IRAS-2
Status last verified
Jan 2026
First submitted
23 Apr 2025
Last updated
26 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Only IPD in the published results will potentially be included.

Questions about this trial

What is this clinical trial studying?

An observational study of Surgical Fatigue, run by Lancaster University at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute muscle activation- percentage of forearm maximal voluntary contraction (%) assessed using EMG frequency. (time frame: Intraoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.

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